JAMA Publishes Analysis of FDA and NIH Withdrawal of DE…
On April 11, 2025 the Journal of the American Medical Association (JAMA) has published a detailed analysis highlighting the potential cons…
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US Department of Commerce Investigates Potential Tarif…
On April 4, 2025, Fierce Pharma published an article discussing the potential impact of President Donald Trump’s tariffs on the biopha…
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US Congress Confirms Martin Makary as FDA Commissioner …
On March 25, 2025, the U.S. Senate confirmed Dr. Marty Makary to lead the Food and Drug Administration (FDA) and Dr. Jay Bhattacharya to hea…
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COFEPRIS (Mexico) Publishes Guidelines for GMP Document…
On March 20, 2025, the Mexican Federal Commission for Protection against Health Risks (COFEPRIS) published in the Official Gazette (DOF) the…
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West Virginia Governor Signs Legislation Prohibiting Ce…
The Governor of West Virginia has signed House Bill 2354 into law, amending §16-7-2 of the Code of West Virginia, 1931. This new legislatio…
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CDE (China) Publishes Guideline for Biologics Registrat…
On February 9, 2025, the Center for Drug Evaluation (CDE) announced the release of the “Guideline for Acceptance Review of Biological …
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Portuguese Industry Opposes U.S. Proposal for Cancer Wa…
The United States Health Authority is considering the introduction of mandatory cancer warning labels on alcoholic beverages, a measure simi…
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US FDA Announces Draft Guidance on AI Use in Regulatory…
On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled “Considerations for the U…
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US FDA Announces Public Meeting on Paediatric Legislati…
The Food and Drug Administration (FDA) has scheduled a public meeting titled “Interested Parties Meeting: Implementation of the Best Pharm…
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FDA (USA) Establishes New Center for Real-World Evidenc…
On December 12, 2024, the U.S. Food and Drug Administration (FDA) announced the creation of the Center for Real-World Evidence and Innovatio…
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